UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Relationship Between Sleep Apnea and Fatty Acid Profiles in Patients Who Underwent Percutaneous Coronary Intervention
Title of the study (Brief title)	Relationship Between Sleep Apnea and Fatty Acid Profiles in Patients Who Underwent Percutaneous Coronary Intervention
Region	Japan

Condition
Condition	Sleep apnea syndrome
Classification by specialty	Medicine in general Cardiology Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify whether the presence and also the severity of sleep apnea in dyslipidemia patients who underwent percutaneous coronary intervention affects the fatty acids profiles.
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Nocturnal oxygen desaturation index and fatty acids concentration
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who were performed PCI and screened SpO2 by nocturnal pulseoximeter
Key exclusion criteria	Patients who meet the following conditions. 1. Patients who requires oxygen support 2. Patients who received EPA treatment on admission
Target sample size	200

Research contact person
Name of lead principal investigator	Kentaro Jujo
Organization	Tokyo Women's Medical University
Division name	Department of Cardiology
Address	8-1, Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL	+81333538111
Email	juken1123@hotmail.co.jp

Public contact
Name of contact person	Kentaro Jujo
Organization	Tokyo women's Medical Hospital
Division name	Cardiology
Address	8-1, Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL	+81333538111
Homepage URL
Email	juken1123@hotmail.co.jp

Sponsor
Institute	Tokyo women's Medical Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Tokyo women's Medical Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 08 Month 01 Day
Anticipated trial start date	2013 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Prospectively enrollment Retrospectively analysis

Management information
Registered date	2016 Year 06 Month 05 Day
Last modified on	2016 Year 06 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026067